A Prospective Study: A Computer Vision Model on a Smartphone Platform for Real-time Evaluation of Serum Bilirubin Through Sclera Images
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Loss of predicted bilirubin levels
研究概览
简要总结
The primary efficacy endpoints are the standard deviation and coefficient of determination (R2) between predicted and actual values for the bilirubin regression model, and the grading accuracy for the jaundice severity classification model. The secondary efficacy endpoint is the mean percentage error between predicted and actual bilirubin values. There are no relevant safety risks.
Statistical differences for categorical variables (e.g., jaundice grading evaluation indicators) will be analyzed using the chi-square test or Fisher's exact probability test. For continuous variables (e.g., bilirubin prediction evaluation indicators), t-tests (normal distribution) or non-parametric tests (non-normal distribution) will be used. The 95% confidence interval for jaundice grading accuracy will be calculated using the Wilson method.
The study duration is estimated to be 3 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 14 years or older. Subjects who are visiting the Gastroenterology Department of Xijing Hospital and will undergo liver function tests on the same day. The disease spectrum of the subjects mainly includes pancreatitis, pancreatic tumors, hepatobiliary stones, biliary tumors, and colonic polyps.
排除标准
- •Subjects with diseases that may cause abnormal changes in scleral color, such as glaucoma, Wilson's disease, pterygium, or scleritis.
- •Subjects who have recently consumed a large amount of carotenoid-rich foods (such as oranges or carrots).
- •Subjects who are unable to provide informed consent.
- •Elimination Criteria:
- •Subjects with incomplete scleral exposure due to limited eye movement or excessive tension during external eye examination.
- •Subjects who are unable to understand the instructions for eye rotation during scleral examination or are unable to cooperate due to reasons such as poor hearing.
结局指标
主要结局
Loss of predicted bilirubin levels
时间窗: Immediately after test completion
Standard deviation and mean average percentage error between predicted and actual bilirubin levels for the bilirubin regression model.
Classification accuracy
时间窗: Immediately after test completion
Classification accuracy for the jaundice severity grading model
次要结局
未报告次要终点
研究者
Yanglin Pan
Professor
Air Force Military Medical University, China